Insights On Quality Assurance

1. When Clean Is Critical—Understanding Parameters And Definitions Of Clean 11/15/2019

   Clean room environments necessitate high-quality materials and equipment that conform to a variety of specified standards. This white paper explains how clean parameters are defined and validated.

2. Using Laser-Based Headspace Moisture Analysis For Rapid Nondestructive Moisture Determination Of Sterile Freeze-Dried Product 12/28/2018

   Rapid water vapor determination with an optical method could replace the slow destructive traditional methods for the moisture analysis of freeze-dried product. A description of industry applications of headspace moisture analysis including freeze drying cycle optimization, lyo chamber moisture distribution mapping, and 100% moisture inspection of commercial freeze-dried product.

3. Assurance Of Quality Supply For Single-Use Pre-designed Solutions 3/18/2019

   Read how resin specifications, process qualification and process controls established at all stages of the manufacturing process can ensure quality, change control and business continuity.

4. Introduction To Laser-Based Headspace Inspection And The Application To 100% Container Closure Inspection 12/26/2018

   Gain insight into the process, ensure the maintenance of sterility for finished product after capping, and meet current regulatory guidance using laser-based headspace inspection.

5. Non-Invasive Headspace Analysis For Automated Media Fill Microbial Inspection 12/28/2018

   Laser-based headspace provides yet another alternative approach for detecting microbial contamination in sterile pharmaceutical product allows for quicker, more sensitive, accurate, and reproducible test results when compared with conventional, growth-based methods.

6. Container Closure Integrity Of Sterile Vials During Deep Cold Storage 12/26/2018

   Learn how rapid, nondestructive laser-based headspace analysis can support with data generation to demonstrate the maintenance of seal integrity during deep cold storage and transport.

7. Formulation Development: Determining Oxygen Sensitivity 6/3/2020

   Pharmaceutical formulations, especially delicate large molecule biopharmaceuticals, may have some level of oxygen-sensitivity leading to degradation of the active pharmaceutical ingredient. Laser-based headspace oxygen analysis enables accurate, efficient determination of oxygen consumption curves. Accurate measurement of the oxidation rate supports the determination of headspace oxygen specifications and end-of-shelf life stability.

8. Using Positive Controls In Container Closure Integrity Studies 1/2/2019

   This webinar describes the use of positive controls as an important element of CCI studies designed to validate packaging components for CCI or to qualify processes for producing good CCI.

9. Quality Stability Testing: Oxygen Monitoring During Shelf Life 6/3/2020

   A manufacturer of a syringe product received complaints about discolored product that was nearing the end of shelf life. A root cause investigation was started and product syringes were put on stability. The headspace oxygen levels were monitored over time. The laser-based headspace analysis proved to be a useful tool to check package integrity and for the presence of reactive headspace gases that can degrade the formulation.

10. CCI Testing And Revisions To EU Annex 1 1/2/2019

    The new language in EU Annex 1 will likely have a significant impact on your CCI testing practices. In this webinar CCI testing strategies and the proposed revisions to EU Annex 1 are discussed.